A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

NCT ID: NCT06493864

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2026-07-31

Brief Summary

This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor.

Conditions

Breast Cancer; Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BL-B16D1

Participants receive BL-B16D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

BL-B16D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

BL-B16D1

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);

4. Expected survival time ≥3 months;

5. Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic breast cancer and other solid tumors who failed or could not receive standard treatment;

6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;

7. Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition;

8. ECOG 0 or 1;

9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulation factor therapy within 14 days before the first dose;

12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;

13. Urinary protein ≤2+ or ≤1000mg/24h;

14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment.

Exclusion Criteria

1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;

2. History of severe heart disease;

3. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block;

4. Active autoimmune and inflammatory diseases;

5. Patients with other malignant tumors or a history of other malignant tumors;

6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;

7. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);

8. Patients with poor glycemic control;

9. Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;

10. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;

11. Patients with primary central nervous system (CNS) tumors or CNS metastases that had failed local treatment;

12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B16D1's excipients;

13. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

14. In previous (new) adjuvant anthracyclines, the cumulative dose of anthracyclines for doxorubicin > 550 mg/m2, epirubicin > 900 mg/m2 or the equivalent dose of other similar drugs;

15. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;

16. Serious infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;

17. Patients with massive or symptomatic effusions, or poorly controlled effusions;

18. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);

19. Had the following eye diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;

20. Other circumstances that the investigator deemed inappropriate for participation in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiong Wu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Jian Zhang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Jiong Wu

Role: primary

Other Identifiers

BL-B16D1-103

Identifier Type: -

Identifier Source: org_study_id